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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name standard polysomnograph with electroencephalograph
510(k) Number K971867
Device Name ALICE 4R SYSTEM
Applicant
HEALTHDYNE TECHNOLOGIES, INC.
1850 PARKWAY PLACE
MARIETTA,  GA  30067
Applicant Contact TIMOTHY Y COWART
Correspondent
HEALTHDYNE TECHNOLOGIES, INC.
1850 PARKWAY PLACE
MARIETTA,  GA  30067
Correspondent Contact TIMOTHY Y COWART
Regulation Number882.1400
Classification Product Code
OLV  
Date Received05/20/1997
Decision Date 08/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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